Rauck, R., North, J., Gever, L.N., Tagarro, I., & Finn, A.L. (2010). Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: A randomized, double-blind, placebo-controlled study. Annals of Oncology: Official Journal of the European Society for Medical Oncology/ESMO, 21(6), 1308–1314.doi: 10.1093/annonc/mdp541
To evaluate the efficacy of fentanyl buccal soluble film (FBSF), at doses of 200–1200 mcg, in the management of breakthrough pain (BTP) in patients with cancer who are receiving ongoing opioid therapy
In phase 1, patients were screened, for up to one week, to assess tolerance of FBSF. In phrase 2, the titration phase, patients started with 200 mcg dose that was increased in a stepwise fashion (200, 400, 600, 800, 1200 mcg) until the patient experienced pain relief. Patients were discontinued from the study if a satisfactory dose could not be determined. If a satisfactory dose was achieved for two BTP episodes, patients proceeded to the double-blind phase. The double-blind phase lasted up to two weeks. Each patient received nine doses of FBSF (six of study medication and three of placebo). A computer determined the order of administration. Patients were allowed to use usual rescue medication if they did not receive adequate pain relief in 30 minutes. Study medication was allowed every four hours.
Randomized placebo-controlled, double-blind, multiple-crossover study
FBSF was more effective than placebo for the treatment of breakthrough pain in patients with cancer. The treatment was well tolerated.
FBSF shows favorable and safe results for the treatment of breakthrough pain, but the treatment remains investigational.